Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD)

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A 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Time-lagged, Parallel Group Study in Patients With Mild to Moderate Alzheimer's Disease (AD) to Investigate the Safety, Tolerability and Aß-specific Antibody Response Following Three Subcutaneous Injections of CAD106

Tolerability/safety assessments (physical/neurol.exam., ECG, vital signs, standard and special immunological laboratory evaluations, MRIs, EEGs, AE/SAE monitoring). [ Time Frame: at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52. ]

Antibody titers (IgM and IgM titers against amyloid and carrier protein). [ Time Frame: at multiple timepoints including but not limited to baseline and through the end of the study to Week 52 ]

Secondary Outcome Measures
:

Immune response, cognitive and functional assessments [ Time Frame: at multiple timepoints including but not limited to baseline and through the end of the study to Week 52 ]

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Ages Eligible for Study:

50 Years to 80 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

males and/or females patients between 50 to 80 years of age (both inclusive).

female patients must be without childbearing potential (post-menopausal or surgically sterilized).

diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders, 4th edition).

mild to moderate AD as confirmed by Mini-Mental State Exam score of 16 to 26 (both inclusive) at screening.

able to provide written informed consent and having a responsible caregiver that can provide written assent prior to study participation. For patients who have been declared mentally incompetent, a legal representative will need to provide informed consent on their behalf.

Exclusion Criteria:

previously participated in an AD vaccine study and received active treatment

history or presence of an active autoimmune and/or cerebrovascular disease

history or presence of seizures, with an acute or chronic inflammation

obtained a vaccination (e.g. against influenza) within 4 weeks before the first study drug injection

advanced, severe, progressive or unstable disease that might interfere with the safety of the patient

started treatment with psychotropic medication within 3 months (4 weeks for SSRIs and other newer antidepressants without anticholinergic properties) prior to randomization with the exception of mild hypnotic drugs (e.g. zolpidem, zopiclone, oxazepam) and low doses of neuroleptic drugs (e.g. up to 2 mg risperidone).

Patients, who are on stable treatment with cholinesterase-inhibitors (ChEIs) and/or memantine for at least 3 months, and/or with SSRIs and/or other newer antidepressants (without anticholinergic properties) for at least 4 weeks before randomization, can be included into the study.